Diagnosis: Conflict of Interest

By Daniel Carlat

June 13, 2007

Boston

THE revelation that the diabetes drug Avandia can potentially cause heart disease is the latest in a string of pharmaceutical disappointments. Vioxx was pulled from the market in 2004 because it doubled the risks for heart attacks and strokes. Eli Lilly recently paid $750 million to settle lawsuits alleging that Zyprexa causes diabetes. Many have criticized the Food and Drug Administration as being too lax about monitoring drug safety.

While those criticisms have merit, there is another culprit: the transformation of continuing medical education into an enterprise for drug marketing. The chore of teaching doctors how to practice medicine has been handed to the pharmaceutical industry. As a result, dangerous side effects are rarely on the curriculum.

Most states require that doctors obtain a minimum number of credit hours of continuing medical education each year to maintain their medical licenses. Not so long ago, most of these courses were produced and paid for by universities and medical associations. But this has changed drastically over the past decade.

According to the most recent data available from the national organization in charge of accrediting the courses, drug-industry financing of continuing medical education has nearly quadrupled since 1998, from $302 million to $1.12 billion. Half of all continuing medical education courses in the United States are now paid for by drug companies, up from a third a decade ago. Because pharmaceutical companies now set much of the agenda for what doctors learn about drugs, crucial information about potential drug dangers is played down, to the detriment of patient care.

For example, GlaxoSmithKline footed the bill for dozens of educational courses intended to emphasize the benefits of Avandia over other drugs. An influential Internet-based educational program paid for by the company focused on specific studies that highlighted Avandia’s advantages without discussing one of the drug’s most worrisome side effects, increased levels of the lipids implicated in heart disease.

Avandia’s chief competitor, a drug from Takeda Pharmaceuticals called Actos, improves lipid levels but was hardly mentioned. When GlaxoSmithKline’s program did cite Actos, it did so tepidly. The information in the course was presented by noted diabetes academics paid by GlaxoSmithKline and other drug companies.

GlaxoSmithKline is not the only offender. The major organizations in diabetes education, like the National Diabetes Education Initiative, offer dozens of continuing medical education courses on diabetes that are free to doctors and paid for by drug companies. Predictably, each course focuses on the advantages of the sponsor’s product and minimizes discussion of dangerous side effects.

Education that doubles as advertising for drug companies occurs in all branches of medicine. Merck promoted Vioxx for arthritis by using programs for continuing medical education, which helped contribute to the more than 100 million prescriptions of the drug before it was pulled from the market.

According to Dr. David Graham, a safety researcher for the Food and Drug Administration, Vioxx was responsible for up to 140,000 cases of serious heart disease from 1999 until 2004, when it was withdrawn. But the potential cardiac dangers of Vioxx were played down in the courses paid for by Merck. In one instance, the company canceled lectures it had sponsored by a Stanford researcher who had mentioned, in talks to doctors, the cardiac risks from taking Vioxx.

Drug companies should never have been allowed to become the primary educator for America’s doctors. The Accreditation Council for Continuing Medical Education, a nonprofit organization composed of the major medical associations, establishes the rules that govern continuing medical education. According to the guidelines, companies are forbidden from directly paying doctors who teach continuing medical education courses.

But the standards have a loophole that allows drug companies to circumvent the regulations. They hire for-profit “medical education communication companies” to organize the courses. These companies receive millions of dollars from drug companies to create course work and to pay doctors to deliver the content. Sometimes, they pay doctors to give lectures to other doctors. Other times, prominent doctors are paid to be listed as the authors of journal articles that are written by ghost writers, a practice that was extensively documented in court records from a lawsuit against Pfizer.

Either way, the content is rarely developed by the identified experts. Instead, it is developed by the undisclosed communication company, which is paid by the sponsoring pharmaceutical company.

Essentially, this is a new twist on that well-known instrument of corruption, money laundering. Drug companies don’t directly pay doctors to teach courses. Instead, they pay someone elseto cut the checks. Similarly, the drug companies don’t explicitly tell doctors to say good things about their products. Instead, they hire a company to write good things about their products and to pay doctors to deliver the messages.

These shenanigans were recently spotlighted by Senator Max Baucus, Democrat of Montana, and Senator Charles Grassley, Republican of Iowa, of the Senate Finance Committee. In April, their committee released a report, two years in the making, concluding that drug companies have used educational grants unethically as a way of marketing their products.

In response, the guidelines regarding commercial support for continuing medical education are being reviewed. The solution could hardly be simpler: any continuing medical education that is paid for by the drug industry should not be accredited. Drug companies could still pay for any educational event, article or pamphlet they choose, but their courses and materials would no longer bear the imprimatur and implied credibility of accreditation.

Doctors, in turn, would be encouraged to seek medical education from sources that are not financed by drug companies. A renewed commitment to unbiased education would allow doctors to learn about drug risks sooner. This would be good for doctors, and even better for their patients.